Prevention and Reduction of Obesity Through Active Living

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: UC (Usual Care Group); Behavioral: BI (Behavioral Intervention Group)

• Registration Number: NCT00665158
• Lead Sponsor: Queen's University

Brief Summary

We will perform a randomized, controlled trial, the primary aim of which is to assess the effectiveness of a behavioral-based physical activity program in the prevention and treatment of obesity and related co-morbid conditions in a primary care setting. We hypothesize that the prevention and/or reduction of obesity and related co-morbidities in patients randomized to an individualized education and behavior counseling group will be greater by comparison to those randomized to a group that receives standard care alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Status Verified: 2008-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Men and women between 25 and 65 years of age.
• Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).
• Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively).
• Weight stable (± 2 kg) for 6 months prior to the beginning of the study.
• BMI between 25 and 34.9 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI greater less than 35, and, that 94% of overweight and obese Canadian adults have a BMI between 25 and 34.9 kg/m2, subjects with a BMI 35 or greater will be excluded).

Exclusion Criteria

• Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia, uncontrolled or insulin dependent diabetes mellitus.
• Alcohol consumption > 21 drinks per week.
• Plans to move from the area.
• Participating in another research study.
• Clinically judged to be unsuitable for participation or adherence
• Inability or unwillingness to provide informed consent.
• For women, planned pregnancy in the next 3 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC	UC (Usual Care Group)	Usual Care Group
BI	BI (Behavioral Intervention Group)	Behavioural Intervention Group

Primary Outcome Measures

Name	Time	Method
Waist Circumference	2 Years

Secondary Outcome Measures

Name	Time	Method
Metabolic Syndrome	2 Years

Trial Locations

Locations (1)

Queen's University : Physical Education Center; 🇨🇦 Kingston, Ontario, Canada